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GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

NCT06309732 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-13

No results posted yet for this study

Summary

St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects.

Conditions

  • Testicular Neoplasms

Interventions

DRUG

Pegfilgrastim

6mg at each cycle

DRUG

Dactinomycin

1mg/m2

DRUG

Methotrexate

Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion

DRUG

Etoposide

90mg/m2 injection for infusion

DRUG

Cisplatin

50mg/m2

DRUG

Epirubicin

37.5mg/m2

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Jonathan Shamash · Barts & The London NHS Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2013-06-30
Completion
2014-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06309732 on ClinicalTrials.gov